R&D Project Lead

Job Description:

The R&D Project Lead will be the key player in R&D project management. The role includes project feasibility analysis and management of pharmaceutical projects up to commercialization including launch readiness. The R&D Project Lead is responsible for the R&D project strategy and operational management of cross-functional teams by applying industry-standard project management tools, processes, and principles to meet timelines and deliverables. This position will interact with almost all company departments in a multidisciplinary team’s matrix organization and will be fully accountable for Project Strategy and Performance. The R&D Project Lead facilitates cross-functional communication and strategic decision-making within project teams and among project sponsors.

Responsibilities:

• Validation of viability and profitability of new projects proposed by the New Product Planning Committee (value proposition, competitive landscape analysis, technical viability, development plan, costs, and target market)
• Develop Target Product Profile, Business Case, R&D Project Plan, and Costs
• Leading the strategic, scientific, and operational planning and decision-making processes of assigned R&D Projects.
• The R&D Project Lead will provide content expertise to the strategy, competitiveness, timing, costs, and resources required for the development project and be able to successfully deliver their project(s) milestones and goals. As the strategic partner and operational lead for development, the R&D Project Lead works to ensure that cross-functional teams operate effectively, fostering positive team dynamics and championing the company’s operating model.
• Responsible for driving the development of an integrated project timeline that represents the appropriate level of detail and task interdependencies. The integrated project plan outlines the project scope, deliverables, and timing for the project and may include various scenarios. Ensures the timeline is aligned with the overall project plan and corporate objectives.
• Work closely with the project sponsors and cross-functional team members to clarify task ownership, manage the coordination of activities, determine critical path activities, proactively track the project plan, monitor variances, and alert the teams and sponsors when there are potential deviations from the plan that will likely impact corporate goals and project milestones. Drives timely and successful resolution of open issues and decisions.
• Works with team members to identify resource constraints, project risks, and conflicts that could impact the project schedule and work with team members and management to develop appropriate solutions. Providing strategic guidance to ‘pressure-test’ program team’s assumptions, driving scenario planning/trade-off analysis, and cross-functional planning into the overall integrated project plan.
• Keep realistic baselines (scope, time & cost)
• Coordinate assigned resources
• Pro-actively monitor project performance and gather Project Performance Data
• Synthesize and track information from the teams for inclusion in monthly status reports and in preparation for periodic project reviews and decision point meetings.
• Ensure team meetings are efficient and meaningful by preparing agendas, facilitating discussions, and publishing minutes and action item logs.
• Exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
• Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, and teamwork.
• Generate and share project information and knowledge
• Manage partners, alliances, and contracts related to assigned projects

Skills required:

• In-depth knowledge of the drug/device development process relevant to the pharmaceutical Knowledge of design controls per FDA Quality System Regulation, risk management per ISO 14971, and ISO 13485 preferred.
• Extensive understanding of the drug development process (i.e., Pharmaceutical Development, Clinical Research, Regulatory Affairs, Medical Affairs, etc.…)
• Extensive understanding of manufacturing operations for system automation and integration, IQ/OQ/PQ, manufacturing scale-up and process validation, CMC, quality and regulatory per design control process (pharma and medical device), packaging/ labeling for a global launch, risk management, and supply chain
• Experience in launch readiness
• External partner management experience, working with (CMOs, CROs, and vendors)
• Able to support highly complex multiple activities simultaneously
• Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations
• The capability of understanding and communicating both scientific and business-related elements of R&D projects
• Team player with sound decision-making skills, able to build strong, sustainable relationships and efficient teams
• Transparent communication and influencing skills
• Empathy, and active listener
• Ability to work both at strategic and operative levels
• Leadership, and capable of allowing expression of ideas/opinions diversity
• Learning agility
• Sense of urgency
• Strong proficiency with project management practices, tools and
• Excellent analytical skills, with an ability to communicate complex issues in a simple way Effective written and oral communication, interpersonal, problem-solving, and facilitation skills. Must be able to prioritize and work independently.
• Requires strong computer skills with proficiency in Microsoft Projects and Microsoft 

Education and experience:

• Bachelor’s Degree in an engineering and/or scientific discipline required with an advanced degree preferred, PhD highly recommended
• A minimum of 5 years of professional experience in the pharmaceutical/biotech industries. Drug delivery and medical device experience are a plus.
• 3+ years of experience in project management, clinical project management, team leadership, and/or functional line management in one or more of the major R&D functions is also required
• Master’s in project management (highly valuable)
• Previous experience in neurodegenerative, pulmonary, or rare disease (highly valuable)

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer
• Potentially prolonged periods of standing
• Must be able to lift up to 15 pounds at times
• Must be willing to travel